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Medical device and procedure simulation and training

US 9,892,659 B2 · Inventors: Zamierowski; David S. et al.

USPTO PDF

Overview

Sheet 1 of 64 from the published document. All sheets in the USPTO PDF

Abstract From the patent

A healthcare simulation system including a mannequin with active physiological characteristics, a display monitor adapted for displaying physiological parameters, and a computer for controlling the mannequin and the monitor. A healthcare simulation method including the steps of programming the computer with healthcare scenarios, operating active characteristics of the mannequin, and dynamically displaying physiological parameters corresponding to patient vital signs. Alternative aspects of the invention include tools, such as computers and other equipment, for obtaining and displaying information and for interconnecting and interfacing participants, subjects and controllers in training systems and methods. Additional aspects of the invention include systems and methods for glucometer simulation and training. An embodiment includes a simulated finger configured for holding simulated blood serum and for puncture with a lancet. The simulated finger is configured for sliding over a standardized patient or mannequin's finger. Alternative embodiments include simulated lifelike replicas of other body parts.

Why it's free to use

  • The USPTO Official Gazette of April 14, 2026 lists it as expired on February 13, 2026 for an unpaid maintenance fee.
  • It isn't on any reinstatement notice published since.
  • Its 1 US relative has also lapsed, expired or never issued.
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FiledJanuary 27, 2017
GrantedFebruary 13, 2018
Expired (fee)February 13, 2026
Application number15/418607
Classification (CPC)G09B23/303 +2 more
Length15 claims · 83 pages

Background From the patent

The field of patient monitoring with electronic display devices, such as bedside monitors, is well-developed and standard for critical (intensive) care units (ICUs) at many institutions and for many surgical procedures. Patient rooms in critical care units and operating rooms (ORs) at many institutions are equipped with monitors, which receive inputs from electrodes and other input instruments connected invasively and noninvasively to patients. The monitors commonly provide displays corresponding to patient data, such as blood pressure, pulse rate, temperature, electrocardiographic heart rhythm strips, central venous pressure, pulmonary artery pressure, cardiac output, intracranial pressure, pulmonary pressure and other signals from catheters and transducers. Ventilator pressure can be utilized in connection with ventilator monitoring. Gas content analyzers can directly display gas parti

Drawings 64

1 of 64 drawing sheets so far from the published document, cropped to the drawing. Every sheet is in the USPTO PDF.

Figures as described

  • FIG. 1 is a block diagram of a healthcare training system embodying a first aspect of the present invention
  • FIG. 2 is a view of a display of a monitor thereof, particularly showing digital display outputs corresponding to patient vital signs
  • FIG. 3 is a view of a display of an alternative monitor thereof, particularly showing patient vital sign parameters at programmable intervals
  • FIG. 5 is a flowchart showing another simulation scenario involving an initial student trainee assessment of the conditions associated with the mannequin
  • FIG. 6 is a block diagram of a healthcare training system embodying a second aspect of the present invention
  • FIG. 7 is a flowchart showing a training session variable initialization procedure therefor
  • FIG. 8 shows the instructor controls and display therefor
  • FIG. 9 shows the student display therefor
  • FIG. 10 shows a typical prior art glucometer, which can be used in connection with an alternative aspect of the present invention
  • FIG. 11 shows a finger cot, which can optionally be used for simulated patient blood serum modeling in connection with an alternative aspect of the present invention
  • FIG. 12 shows the finger cot being punctured by a lancet instrument for obtaining a simulated blood serum sample on a reagent strip
  • FIG. 13 shows a simulated blood serum sample being drawn for application to the reagent strip

Claims 15 total, 3 independent

What the patent claimed, word for word. All of it is now free to use.

  1. 1
    Independent claimA simulated human body part configured for placing on a subject and supplying a simulated body fluid sample, which body part includes: a shield configured for placing in a protective position on the subject; a bleb configured for placing on the shield and containing a quantity of simulated body fluid; said bleb for puncturing and discharging a simulated body fluid sample; and a retaining structure securing said bleb on the subject in a fixed position relative to said shield.
  2. 2
    The simulated part according to claim 1, which includes: said shield having a contoured configuration forming a receiver configured for receiving a subject finger.
  3. 3
    The simulated part according to claim 2, which includes: said bleb including inner and outer layers; and said simulated fluid being placed between said bleb layers.
  4. 4
    Independent claimA fluid analysis simulation and training system comprising: an interface having a contoured surface configured for placement over a standardized patient or mannequin's finger having a contoured finger surface; wherein said interface contoured surface is configured for mating with said contoured finger surface; wherein said interface includes a simulated finger having at least one bleb configured for containing a quantity of liquid simulating a patient fluid; and an extracting instrument for puncturing and extracting said simulated body fluid from said at least one bleb.
  5. 5
    The fluid analysis simulation and training system according to claim 4, further comprising: a glucometer configured for analyzing said extracted fluid; wherein said simulated body fluid is configured for simulating blood; and wherein said glucometer is configured for determining glucose levels of said simulated blood.
  6. 6
    The fluid analysis simulation and training system according to claim 4, wherein said simulated finger further comprises: a fillable reservoir connected to said at least one bleb configured for being filled with said simulated body fluid; and wherein said at least one bleb is configured for being filled by applying pressure to said fillable reservoir.
  7. 7
    The fluid analysis simulation and training system according to claim 6, wherein: said interface further comprises a layer of protective material configured for protecting said standardized patient or mannequin's finger from puncture; said simulated finger includes a proximal end reservoir opening; and said layer of protective material includes a cap configured for fitting over, compressing, and sealing the edges of said proximal end reservoir opening.
  8. 8
    The fluid analysis simulation and training system according to claim 7, wherein said layer of protective material further comprises: a flange configured for insertion inside said proximal end reservoir opening and for preventing puncture through both sides of said reservoir when said reservoir is filled with said simulated body fluid.
  9. 9
    The fluid analysis simulation and training system according to claim 7, further comprising liquid sealant configured for further sealing said edges of said proximate end reservoir opening together and to said layer of protective material.
  10. 10
    The fluid analysis simulation and training system according to claim 1, which includes: an output subsystem including a monitor configured for displaying a standardized patient condition.
  11. 11
    Independent claimA fluid analysis simulation and training method including a simulated finger having at least one bleb configured for containing a quantity of liquid simulating a patient fluid, which method comprises the steps of: filling said at least one bleb with standardized patient fluid; placing said simulated finger on a standardized patient or mannequin's finger; pricking one of said blebs with an extracting instrument; extracting a droplet of said standardized patient fluid from said pricked bleb; and a glucometer analyzing said extracted fluid.
  12. 12
    The method according to claim 11, wherein said simulated finger further comprises a fillable reservoir connected to said at least one bleb, the method further comprising the steps of: filling said fillable reservoir with standardized patient fluid; and wherein said filling said at least one bleb with standardized patient fluid comprises applying pressure to said fillable reservoir, pushing said standardized patient fluid into said at least one bleb.
  13. 13
    The method according to claim 11, wherein said simulated finger includes a proximal end reservoir opening, the method further comprising the step of: sealing said simulated finger proximal end reservoir opening.
  14. 14
    The method according to claim 13, wherein said simulated finger includes a layer of protective material configured for resisting puncture and including a proximal end cap configured for sealing said simulated finger proximal end reservoir opening, the method further comprising the steps of: applying sealant to the edges of said simulated finger proximal end reservoir opening and said layer of protective material; inserting said reservoir opening edges into said cap; and said cap compressing said reservoir opening edges and sealing said reservoir opening.
  15. 15
    The method according to claim 11, further comprising the steps of: applying sealant to the outside of the puncture hole in said pricked bleb; and allowing said sealant to dry prior to subsequent use of said simulated finger.

Claim map

Independent claims stand on their own. The others add detail to the claim they name.

Claim 13 claims build on it
Claim 45 claims build on it
Claim 114 claims build on it

Description

Background of the invention

1. Field of the invention

The present invention relates to healthcare simulation, and in particular to a portable, dedicated display device, such as a touch-screen monitor, for displaying simulated, noninvasively-obtained vital signs from a healthcare instructional scenario programmed into a computer for conducting the scenario and controlling the monitor display and the simulated physiological functions of a mannequin or other patient model corresponding to the displayed vital signs. The present invention also relates to medical devices and procedures, and more particularly to medical device and procedure simulation and training systems and methods.

2. Description of the related art

The field of patient monitoring with electronic display devices, such as bedside monitors, is well-developed and standard for critical (intensive) care units (ICUs) at many institutions and for many surgical procedures. Patient rooms in critical care units and operating rooms (ORs) at many institutions are equipped with monitors, which receive inputs from electrodes and other input instruments connected invasively and noninvasively to patients. The monitors commonly provide displays corresponding to patient data, such as blood pressure, pulse rate, temperature, electrocardiographic heart rhythm strips, central venous pressure, pulmonary artery pressure, cardiac output, intracranial pressure, pulmonary pressure and other signals from catheters and transducers. Ventilator pressure can be utilized in connection with ventilator monitoring. Gas content analyzers can directly display gas partial pressures for anesthesiology and measured and calculated ventilator pressures for pulmonary functions.

Patient physiological instrumentation and monitoring equipment can provide output in a wide variety of formats corresponding to instantaneous (real-time) and historical patient data and vital signs. Analog (e.g., continuous wave-form) and digital readout displays and graphical user interfaces (GUIs) are utilized in existing equipment. Physiological variables can be sampled at predetermined intervals for tracking and displaying trends whereby healthcare practitioners can identify and appropriately respond to improving and deteriorating patient conditions.

Computer systems are currently used in the field of patient simulation for healthcare training and education. Mannequins (or manikins) are currently used for training exercises in which they are programmed to automatically model various lifelike symptoms and physiological responses to trainees' treatments, such as normal and abnormal cardiac and respiratory physiology and functions. They can be programmed with various scenarios for instructional simulation of corresponding physiological conditions and specific healthcare problems. For example, Medical Education Technology, Inc. (METI) of Sarasota, Fla.; Gaumard Scientific Company of Miami, Fla.; and Laerdal Medical Corporation (U.S.) of Wappingers Falls, N.Y. all provide patient simulator mannequins, which are adapted for simulating cardio-pulmonary performance with simulated electrocardiogram (EKG) outputs. Such simulation systems enable students to train and learn in settings that closely resemble actual clinical settings and enable practicing on inanimate mannequins. Training under conditions which closely approximate actual clinical patient scenarios will improve patient care and outcomes. Students will have increased levels of skill and competency prior to providing care to actual patients by training under conditions which closely approximate actual clinical patient scenarios. Such automated simulation systems have been successfully utilized in training for specialized procedures and settings, such as cardio-pulmonary, intensive care, anesthesiology, pilot training in flight simulation, etc.

More basic mannequins have been employed for instructing students on a wide range of procedures and treatment scenarios, and provide an alternative to instruction on “live” patients or “standard” patients (e.g., actors, other students and instructors). Thus, the patient models adaptable for use with the present invention range from such “live” patients acting roles to abstract, virtual patients, including avatars and holograms.

The use of glucometers measuring blood sugar (glucose) levels from blood samples has increased dramatically as the incidence and prevalence of diabetes has increased. Because of this trend, the need for a simulation model for a glucometer for teaching at all levels of care for diabetic patients has increased correspondingly. Simulation of testing blood sugar levels with a glucometer can be extremely valuable for training medical practitioners as well as for training diabetic patients to use a glucometer at home.

As the sophistication of simulation scenarios for healthcare teaching has increased in realism and fidelity, the perceived need to train in conditions closely simulating actual medical situations has become more generally recognized. The importance of and the need for these types of portable simulation adjuncts and auxiliaries has become more critical. For example, glucometers represent an example of a medical diagnostic instrument used routinely worldwide for the benefit of large numbers of patients. Diabetic patients tend to use glucometers frequently and regularly. They are also used for monitoring, diagnosing and facilitating the treatment of other blood-glucose level related conditions. Many glucometer users lack formal medical education and would benefit from practical, hands-on training. Anatomically and physiologically accurate simulation of pricking a finger, obtaining a blood droplet, and testing with a glucometer would be extremely valuable medical training.

Effective medical training in the use of glucometers and other devices could improve the overall quality of healthcare universally. The training systems and methods of the present invention are adapted for effective training in scenarios closely mimicking actual patient conditions and physiological responses. Such training scenarios can be reliably replicated for universally consistent training and for standardizing the medical training experiences of students and practitioners. For example, new procedures and treatment techniques can be quickly and easily distributed to all users of the present invention. Such distribution and appropriate software upgrades could occur wirelessly over the Internet “in the cloud.” Training and testing results could also be efficiently distributed using the Internet. Student evaluations and training certifications can be handled remotely and efficiently via high-speed Internet connections and cloud-based computing, including data storage and transfer.

Medical device simulation can also benefit from current modeling technology, including 3-D printing. Equipment, medical device components and patient interfaces can be accurately and efficiently created and replicated using such technology. Customizable devices and patient-specific interfaces can be produced in 3-D model form for simulation and training. For example, patient-specific templates can be used by appropriate computer technology for producing customized medical devices. Patient fittings and adjustments can thus be handled efficiently and accurately. Equipment components can also be modeled for familiarizing students with their general configurations and operational characteristics.

Summary of the invention

In the practice of an aspect of the present invention, a portable healthcare simulation system and method are provided that utilize a mannequin, from a passive doll to a high-fidelity simulator for displaying certain physiological characteristics obtained noninvasively. A display device comprising a monitor displays vital signs in continuous (real-time) or digital time line modes of operation. The system is controlled by a computer, which can be programmed with various scenarios including outputs responding to various treatment procedures and mannequin control signals. Alternative aspects of the invention include a finger cot or finger splint for providing simulated blood serum and a wide variety of tools for interconnecting participants, components and information, all for use in connection with the present invention.

In the practice of other aspects of the present invention, a medical device simulation and training system includes a computer programmed with medical scenarios, including the inputs and outputs corresponding to a variety of patient conditions. Time-varying parameters can correspond to patient condition improvement and deterioration. Moreover, changes in patient conditions can be time-compressed, time-expanded and paused for training purposes. For example, students can observe immediate patient responses to various treatments, which might develop over hours or days in real-time. Instructors can pause exercises and training procedures as needed to emphasize certain patient physiological condition trends and revise treatments as necessary to affect and determine outcomes.

In the practice of alternative aspects of the present invention, a computer simulation can be implemented via a mannequin or a live subject, such as a volunteer. “Standard Patient” (“SP”) physiological parameters and conditions can be preprogrammed. Student interface can be accomplished via devices for conveying simulated patient conditions. Actual diagnostic and monitoring devices can be employed for realism. For example, a stethoscope can be modified with speakers for simulating the audible indicators of physiological parameters, including cardio, pulmonary, gastro-intestinal (“GI”), etc.

Controllers, e.g., instructors, can remotely manipulate the training exercises via touch-screen inputs and other control devices. Patient models can be projected on screen for activating touch-screen selection of particular patient conditions. Intensity, timing and other variables can likewise be instructor-controlled.

In other aspects of the present invention, simulated substances, such as blood serum, can be extracted for analysis with actual devices, such as glucometers. The aspects and embodiments discussed below can accommodate punctures by lancets with corresponding extraction of simulated blood serum. In an embodiment of the invention, a finger splint is utilized with a blood serum-filled bleb on each of the right and left sides of the finger splint for simulation of testing blood-glucose levels without actually puncturing a mannequin or subject's finger. Student participants can thus experience the procedures in nearly real-time conditions. The timing of such condition changes can simulate patient conditions and provider inputs.

However, heretofore there has not been available an automated, portable simulation system and method utilizing a passive or semi-active mannequin with a dedicated monitor and a computer for conducting scenarios with concurrent (real-time) or time-delay display of basic vital sign physiological information, which can be obtained noninvasively, with the advantages and features of the present invention, nor has there been available a glucometer simulation and training system and method with the advantages and features of the present invention.

Brief description of the drawings

FIG. 1 is a block diagram of a healthcare training system embodying a first aspect of the present invention.

FIG. 2 is a view of a display of a monitor thereof, particularly showing digital display outputs corresponding to patient vital signs.

FIG. 3 is a view of a display of an alternative monitor thereof, particularly showing patient vital sign parameters at programmable intervals.

FIG. 4 is a flowchart showing a simulation scenario embodying an aspect of the method of the present invention, which can be adapted to various condition-specific and patient-specific scenarios.

FIG. 5 is a flowchart showing another simulation scenario involving an initial student trainee assessment of the conditions associated with the mannequin.

FIG. 6 is a block diagram of a healthcare training system embodying a second aspect of the present invention.

FIG. 7 is a flowchart showing a training session variable initialization procedure therefor.

FIG. 8 shows the instructor controls and display therefor.

FIG. 9 shows the student display therefor.

FIG. 10 shows a typical prior art glucometer, which can be used in connection with an alternative aspect of the present invention.

FIG. 11 shows a finger cot, which can optionally be used for simulated patient blood serum modeling in connection with an alternative aspect of the present invention.

FIG. 12 shows the finger cot being punctured by a lancet instrument for obtaining a simulated blood serum sample on a reagent strip.

FIG. 13 shows a simulated blood serum sample being drawn for application to the reagent strip.

FIG. 14 shows the simulated blood serum sample on the reagent strip.

FIG. 15 shows a prior art monitor/defibrillator adapted for use in connection with an alternative aspect of the present invention.

FIG. 16 is a block diagram of multiple applications, equipment, participants and configurations of various aspects of the present invention.

FIG. 17 is a schematic diagram of a device and procedure simulation and training system embodying another aspect of the present invention, with instructor and student touch-screen monitors.

FIG. 18 is an enlarged diagram of an instructor touch-screen monitor comprising an input/output (I/O) device for use with the system, taking generally within area 18 in FIG. 17 .

FIGS. 19-27 show additional alternative embodiments of the present invention with finger cots, puncture-resistant shields and serum-filled blebs for glucometer training simulations embodying additional alternative aspects of the present invention.

FIG. 28 shows a top, perspective view of an embodiment of a blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir for training with a fluid analyzer.

FIG. 29 is a side, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 30 is a front, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 31 is a back, elevational view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 32 is a top, plan view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 33 is a bottom, plan view of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 34 is an XY-plane cross-sectional, top, perspective view of the back portion of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 35 is a XZ-plane cross-sectional, top, perspective view of the bottom portion of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 36 is a YZ-plane cross-sectional, top, perspective view of one side of the blood serum interface including a simulated finger with two fluid-holding blebs and a common fillable reservoir.

FIG. 36 a shows a perspective view of a protective shield for clipping over a finger under the interface.

FIGS. 37-43 show another modified embodiment of a blood serum interface including a finger splint mounting two fluid-holding blebs and a common fillable reservoir for training with a fluid analyzer.

FIGS. 44-49 show another modified embodiment of a blood serum interface.

FIGS. 50-52 show another modified embodiment of a blood serum interface.

FIG. 53 shows another modified embodiment of a blood serum interface.

FIG. 54 shows a side, elevational view of an embodiment of a blood serum interface including a simulated finger and a protective shield and sealing wedge combination.

FIG. 55 shows a top, back, exploded, perspective view of the blood serum interface including a simulated finger and a protective shield and sealing wedge combination.

FIG. 56 is a cross-sectional view of the blood serum interface including a simulated finger and a protective shield and sealing wedge combination showing reticulated, open-cell foam within the simulated finger.

FIG. 57 shows a dorsal, proximal, exploded, perspective view of an alternative embodiment of a blood serum interface including a simulated finger and a protective shield and sealing cap combination.

FIG. 58 shows dorsal, proximal, assembled, perspective view of the blood serum interface including a simulated finger and a protective shield and sealing cap combination with a cut out in the protective shield and cap.

FIG. 59 shows a close-up, cross-sectional view of the protective shield and sealing cap combination sealing the proximal end of the simulated finger.

FIG. 60 shows a close-up, cross-sectional view of an alternative embodiment of a protective shield and cap combination including a sealing wedge configured for further sealing the proximal end of the simulated finger.

FIG. 61 shows a partially-exploded, proximal, perspective view of a blood serum interface including a simulated finger and a protective shield, sealing cap, and sealing wedge combination.

FIG. 62 shows a dorsal, plan view of an embodiment of a blood serum interface embodying the present invention, including a protective shield and a penetrable cover.

FIG. 63 shows a distal, elevational view of the protective shield of the blood serum interface.

FIG. 64 shows a side, exploded, elevational view of an embodiment of the blood serum interface including a protective shield and a penetrable cover.

FIG. 65 shows a side, elevational view of the fully-assembled blood serum interface.

FIG. 66 is a dorsal, plan view of a blood serum interface with an alternative embodiment of a penetrable cover.

FIG. 67 shows a side, exploded, elevational view of the blood serum interface including a protective shield and a penetrable cover including fluid receptacles.

FIG. 68 is a side, elevational view of the fully-assembled blood serum interface.

FIG. 69 shows a dorsal, proximal, exploded, perspective view of a blood serum overlay cap portion of a further embodiment of a blood serum interface embodying the present invention.

FIG. 70 is a YZ-plane cross-sectional, dorsal, proximal, perspective view of the overlay cap portion of the blood serum interface.

FIG. 71 shows a dorsal, proximal, exploded, perspective view of the overlay cap with a sealed filling spout.

FIG. 72 shows a dorsal, proximal, perspective, assembled view of the overlay cap portion of the blood serum interface.

FIG. 73 shows a dorsal, plan view of the blood serum interface including a protective shield, a skin-like cover, and a blood serum overlay cap.

Detailed description of the preferred embodiments

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure.

Certain terminology will be used in the following description for convenience in reference only and will not be limiting. For example, up, down, front, back, right and left refer to the invention as oriented in the view being referred to. The words “inwardly” and “outwardly” refer to directions toward and away from, respectively, the geometric center of the embodiment being described and designated parts thereof. Said terminology will include the words specifically mentioned, derivatives thereof and words of similar meaning.

Referring to the drawings in more detail, the reference numeral 2 generally designates a portable healthcare simulator system embodying aspects of the present invention. Without limitation on the generality of useful applications of the system 2 , it is particularly adapted for training healthcare practitioners in assessing and treating various patient conditions under replicated clinical conditions using programmed “scenarios” with a human-like patient simulator or mannequin 4 exhibiting vital signs and life-like physiological responses in an educational environment. The scenarios can be programmed into a system computer 6 , which controls the mannequin 4 and provides output to system output devices 10 .

The system 2 can be configured with various components and can operate standalone or be connected to other systems, e.g., via a server 3 connected to the Internet (worldwide web) 5 whereby multiple mannequins 4 can be linked and controlled in multiple institutions, which can be widely geographically distributed. The term “computer” is broadly used to encompass logic automated control devices, including microprocessors, personal computers, mainframes, etc. The computers disclosed herein typically include such components as memory, inputs and outputs for connection to various peripheral devices, such as the output devices 10 , which can include monitors, printers, telecommunications, data storage, etc. The system computer 6 accepts inputs from various sources, including the mannequin 4 and various input devices, such as keyboards. Moreover, the scenarios and their corresponding patient condition sets can be programmed into the system computer 6 or downloaded to its memory via suitable media, such as CDs or DVDs, or via an Internet (worldwide web) connection.

One or more of the components of the system 2 can be portable for accommodating training needs in various locations, e.g. different rooms in particular facilities and in multiple facilities. Interconnections can be hardwired or wireless using various interconnectivity technologies, as appropriate.

The mannequin 4 can be provided with its own computer 14 , which can be programmed to provide various, life-like physiological functions and corresponding outputs in response to corresponding inputs. For example, pulmonary and cardiac functions such as breathing and pulse can be programmed to vary as appropriate for various patient physiological “conditions.” Other physiological functions, such as eye movement, can also be provided. Still further, the mannequin 4 can be interactive and can include an audio output source for speaking monologue patient comments and complaints concerning various symptoms. Such mannequins are capable of providing simulated EKG (electrocardiogram) output through lead attachment points to a suitable, external cardiac monitor. In addition to the EKG output, other “patient” physiological information comprising part of the outputs of the mannequin 4 can preferably be obtained noninvasively using sensors and equipment 8 for such physiological condition parameters as blood pressure, pulse, SpO2, TCpO2, temperature and others. Alternatively, such simulated patient physiological information can be generated and output to the output devices 10 , 18 by the system computer 6 , and in a training scenario would be virtually indistinguishable from comparable equivalent outputs from the mannequin 4 and its computer 14 .

The mannequin 4 can also include a calibrated fluid pressure control pump mechanism capable of delivering fluid pressure corresponding to the patient blood pressures for the programmed scenarios. Various other physiological functions can be simulated with the mannequin 4 and incorporated in the scenarios. The mannequin computer 14 can control its various functionalities, e.g. in a standalone mode of operation or in conjunction with the system computer 6 . Multiple mannequins 4 can be provided and their computers 14 networked to the system computer 6 , which can function as a server in this system architecture. As noted above, the system computer 6 can be networked with other computers, including a server 3 , and ultimately networked to the Internet 5 . Components of the system 2 can be linked in an appropriate network, i.e. LAN or WAN, whereby scenarios can be shared among students, including remotely for virtual classroom types of applications.

The system output devices 10 can include a monitor connected to the computer 6 . The term “monitor” is used in the broad sense to include various types of displays and GUIs appropriate for the particular applications of the system 2 . Auxiliary output devices 18 can be hardwired (hardwired connections indicated at 25 ) or wirelessly connected (wireless connections indicated at 27 ) to the mannequin 4 or to the computer 6 directly as a supplement to or in place of the system computer output devices 10 . For example, the auxiliary output devices 18 can display, print, record, transmit, etc. the simulated outputs of the sensors and equipment 8 corresponding to simulated physiological variables associated with the mannequin 4 , which can include its own computer 14 , or be completely passive. The sensors and equipment 8 can be hardwired or wirelessly connected to the auxiliary output devices 18 , the mannequin computer 14 and/or the system computer 6 . The sensors 8 are adapted to interface with the mannequin 4 and can comprise a wide variety of conventional medical instrumentation, such as: cuffs for blood pressure (BP); pulse oximetry sensors for clipping on a finger of the mannequin 4 and sensing pulse, SpO2 and TCpO2; thermometers; and other devices. The sensors 8 are preferably of the noninvasive type and either comprise actual medical instrumentation or are adapted for realistically interfacing with the mannequin 4 .

An example of an auxiliary monitor 20 is shown in FIG. 2 and can comprise, for example, a handheld unit with a display screen 22 for receiving the output of the mannequin computer 14 and/or the sensors 8 . By way of example and without limitation on the generality of useful information that can be displayed on the auxiliary monitor 20 , a basic set of vital signs comprising blood pressure (BP), pulse, oxygen saturation in percent (SpO2) and temperature is displayed on the monitor display 22 , as shown in FIG. 2 . A fifth parameter comprising transcutaneous oxygen tension (TCpO2) can be utilized in place of SpO2, particularly for pediatric scenarios. The use of these parameters will be described below.

Blood pressure is conventionally represented by systolic over diastolic. Digital readouts are shown for the vital sign parameters, but one or more could be replaced or supplemented with analog displays. The most recent blood pressure reading can be held on the display screen or GUI 22 of the monitor 20 until the next reading is “taken” (or computer-generated via computer simulation). A blood pressure sensing mechanism can be used for reading the actual pressure on the mannequin's arm or, alternatively, the system computer 6 or the mannequin computer 14 can inflate and deflate a blood pressure cuff, and generate an audible tone (i.e., “beep”) with a simulated pulse in the usual manner, except that the blood pressure signals can be completely controlled and generated by the computers 6 and/or 14 . In this configuration the mannequin 4 is passive, with the computer(s) generating all of the active commands, signals, inputs, outputs, etc.

The computer 6 can be programmed to obtain blood pressure values and display same at programmable intervals, e.g. 1-60 minutes. A simplified output would provide the most recent blood pressure readings only. As shown in FIG. 2 , the BP acquisition time is displayed, along with the current time. The monitor 20 displays patient parameters obtained noninvasively and is preferably coupled to the mannequin 4 and the system computer 6 (e.g., hardwired, wireless or network) for interfacing (graphically and otherwise) with the users for simulation healthcare training.

The system 2 provides a “duality” whereby vital sign inputs and outputs can be obtained from the mannequin 4 , the computer 6 , or both. In a classroom setting, an instructor or instructors can oversee training exercises on the monitor output device 10 connected to the system computer 6 , while the students/trainees directly observe mannequins 4 and/or vital sign readings on displays 22 . Student/trainee performances can thus be monitored on site, or even remotely. Record and playback features of the system 2 permit post-scenario evaluations and critiques. Still further, a live subject could be utilized for one or more of the vital sign inputs, with others being computer-generated in order to simulate virtual medical conditions and output simulated virtual patient “responses” to various treatments.

FIG. 3 shows a modified or alternative display 24 displaying a digital time line or history 26 indicating patient parameters taken at programmed intervals. For example, blood pressure readings can be “taken” (or generated by the computers 6 , 14 according to the program or scenario being run) at suitable time intervals, which can be either predetermined or selected by the students as part of a training exercise. Along with the blood pressure readings, instantaneous values corresponding to the other patient parameters can be taken or computer-generated. In the example display 24 shown, the last five readings are displayed digitally at 26 to provide a recent patient history and identify trends, which could be symptomatic and provide indications of various assessment and intervention options. This feature enables detecting and tracking vital sign “trends,” which can provide important information concerning the patient's improvement or declining condition based on his or her records over periods of time. All of the parameters/vital signs can be tracked with respect to time in this manner and the computer 6 can be programmed for suitable time intervals (t). More or fewer time line entries can be retained and/or displayed. The display 24 can comprise an auxiliary output device 18 ( FIG. 1 ), or it can be incorporated in the system output devices 10 , for example, as an optional screen display or window in a main monitor display accessible through a pull-down menu. The computer 6 can also be programmed to provide digital time lines specific to one or more patient parameters.

In addition to normal real-time operation of the display devices 10 and 18 , the computer 6 can be programmed to compress or expand time in order to conduct efficient training exercises. For example, blood pressure readings that might normally change at hourly intervals can be programmed to change at 10-minute intervals in order to accelerate the simulated changes in patient condition and provide students and trainees with appropriate training on assessing and treating unstable patients in response to changes in their vital signs, including compressed reaction times to such trainee treatments. Other vital signs can be programmed to change at corresponding compressed or expanded intervals. Still further, intervals can be extended to provide a “slow-motion” or “freeze-frame” changing-condition experience as appropriate for particular training scenarios.

Still further, the computer 6 can perform a record-keeping function whereby such changes are recorded and stored to a patient's file. Saved data can be recalled and displayed in order to determine the patient's history and trends and for purposes of comparison with present readings. Users can trigger or initiate repeat vital sign reading procedures for determinations on-demand and in real-time at predetermined or desired time intervals. Predetermined numbers of prior readings can be recalled for comparison with current readings.

Although only a limited number of lines of data are displayed at a time, the system computer 6 memory can be designed to store large amounts of data for multiple virtual patients, which can be identified by patient number. Such data can be retrieved and displayed in various formats, including an interactive “scrolling” display whereby an operator can scroll forward and backward while displaying a limited amount of data at a time. The default display can be the current and the most recent values.

The computer 6 can store data applicable to different “patients” and scenarios. Thus, for training and education purposes patient profiles can be created and subjected to different scenarios in order to provide instructional variety and realism. Of course, some of the vital signs would change more or less quickly than others, whereby different time references for the different vital signs can be utilized as appropriate. Temperature and SpO2, for example, would tend to change relatively gradually, as compared to, for example, pulse and blood pressure.

A pulse-oximeter sensor function (mannequin 4 , computer 6 or both) can emulate the performance of a helium-neon (“he—ne”) laser light type of sensor, which is clipped on a fingertip. An intermittent mode of operation can be provided whereby the oximetry result can be displayed and the result recorded. The sensor 8 and the display monitor 10 can then be removed. Temperature, pulse, and SpO2 could be displayed continuously in real-time, or compared over time with blood pressure (BP) trends. The default timing for pulse, temperature, and SpO2 recording can be keyed on whenever a blood pressure value is also recorded, but different times for just these other readings can also be used.

The monitor display 22 content may be determined, at least in part, by the particular mannequin 4 , which may include software for controlling its operation, i.e., active responses in the form of outputs to various procedures in the form of inputs. The healthcare simulation mannequin 4 preferably provides certain noninvasive patient monitoring functionalities and simulated physiological functions, such as breathing, heartbeat, blood pressure (BP), temperature, audible output, eye/eyelid movement, etc. Input and output signals for the various components of the system 2 can be transferred via connecting cables or wirelessly. Preferred hardwired connections are shown by continuous lines 25 and preferred wireless connections are shown by broken lines 27 in FIG. 1 , although many other combinations of connections are possible.

The temperature function is preferably capable of both intermittent and continuous real-time display for this modality. Patient temperature generally corresponds physiologically to the other parameters of the program according to the particular scenario being utilized. In other words, temperature is an important indicator of physiological condition, and trends (both increasing and decreasing) can inform practitioners of changing conditions and treatment efficacies. Like blood pressure, it can be useful to display temperature in relationship to a time line (e.g., FIG. 3 ), including an indication of when it was last obtained. Also like blood pressure, the temperature can be controlled by existing scenario software loaded on the computer 6 , which is not always the same as real-time and may be capable of manipulation. The mannequin 4 can be temperature-passive, i.e. providing no output signal corresponding to patient temperature. However, passive instruments, such as dummy tympanic membrane temperature probes can be provided for simulating the temperature-taking procedures in the scenarios. Sensors are available for quickly obtaining measurements (e.g., from the ear canal), which can be simulated by the scenario software and the computer 6 .

The system 2 is preferably capable of incorporating continuous temperature displays associated with continuous monitoring, which can be achieved with existing equipment. It will be appreciated that the range of thermometers and temperature sensors is relatively large, whereby the system 2 can be programmed to simulate the operation and outputs associated with such a wide range of temperature input devices. The system 2 can be programmed for simulated temperature readings from different sources, such as axillary, oral, etc., and the scenarios can reflect temperature readings obtained by students from such different sources. Both Centigrade and Fahrenheit readings are available. Pediatric, neonatal, post-anesthesia, sensory depressed, comatose and medicated patients may require and will tolerate continuous temperature sensing from instruments which can be continuously left in place, such as a rectal temperature probe. Continuous temperature sensing in awake or awakening patients can be accomplished with suitable noninvasive surface equipment, such as forehead strips, axillary and skin-surface probes. Just as it is currently possible to use an actual working portable automated blood pressure monitor on existing mannequin models with controlled hydraulic conduits that simulate bronchial arteries, and just as it is possible to use current actual clinical intensive care monitors to pick up cardiac rhythms from predetermined electrical outlets on the mannequin, so it is possible to design a mannequin with vital sign outputs that would enable staff training with their own actual portable automated vinyl signed display devices (VSDD). All output points are controlled by the mannequin and system computer working in concert with the programmed scenario. The blood pressure would be projected by the hydraulic palms in the system as described above. The temperature signal would be transmitted by carefully controlled thermal plates located at strategic points. These can include a plate as the tympanic membrane producing a temperature control chamber in the ear for a scope-type thermal probe, and a plate against the lingual jaw inside and out for an oral probe and a spot on the forehead for a skin surface probe, etc. A specific mannequin model can be equipped with a single play or any combination. The same duality applies to the choices for all the signal output sides for all signals. The SpO2 output signal could be computer-controlled, synchronized infrared and red light output that would simulate the actual transmitted red signal for a specific level of saturation and pulse. This could be transmitted from the mannequin and a designated spot, e.g., the nailbed level of the ring finger. The sensing clip can be oriented so that the receptor signed his against the output sign of the finger. Alternatively, the output signal could be obtained from both the dorsal and the lingual sides of the mannequin finger so that, as in actual practice, it would not matter with the orientation and it is a “transmitted” through signal.

On-demand display of clock time (e.g., 24-hours or other suitable time period) can be coordinated to the time frame chosen for the scenario, or real-time. Preferably the scenario can be started at any chosen time, which “sets the clock” or starts the clock running to set in motion a series of programmed physiological occurrences affected by inputs corresponding to the treatment procedures and scenario plan. The computer 6 also preferably enables “pause” functionalities whereby immediate instruction and feedback can be provided in order to facilitate the instructional aspect of the exercise. Thus, instruction can be timely provided with the simulated patient's condition suspended in pause mode without further deterioration of the patient's physiology. Of course, such deteriorating (or improving) patient conditions can be programmed into the scenarios in real-time for greater realism, or even accelerated to demonstrate the consequences to the patient of various conditions and/or treatments. Also, by selecting key moments and running them in sequence, a cycle which would normally occur over several days can be time-compressed into hours.

The description continues in the full USPTO document.

Timeline & family

Timeline From USPTO dates

2008201020122014201620182020202220242026Earliest priority dateMay 21, 2007Application filedJan 27, 2017Application publishedMay 18, 2017Patent grantedFeb 13, 20183.5-year fee paidAug 13, 20217.5-year fee not paidAug 13, 2025Patent expiredFeb 13, 2026

Maintenance fees

Fees are due 3.5, 7.5 and 11.5 years after grant. This patent expired on February 13, 2026, so the fee marked "not paid" was the one that went unpaid.

3.5-year feeDue August 13, 2021Paid
7.5-year feeDue August 13, 2025Not paid
11.5-year feeDue August 13, 2029Never came due

US family 2 documents, by filing date

Published applicationUS 2017/0140673 A1

MEDICAL DEVICE AND PROCEDURE SIMULATION AND TRAINING

Filed Jan 2017 · published May 2017
Published application
This documentUS 9,892,659 B2

Medical device and procedure simulation and training

Filed Jan 2017 · granted Feb 2018
Lapsed, fee not paid

Earlier publications, parents and continuations. None of them can still be enforced, or this patent would not be listed.

Sources & verification

Verification

  • The USPTO Official Gazette of April 14, 2026 lists it as expired on February 13, 2026 for an unpaid maintenance fee.
  • It isn't on any reinstatement notice published since.
  • Its 1 US relative has also lapsed, expired or never issued.
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